(36 days)
Not Found
No
The document describes a galvanic stimulator and does not mention AI or ML in the device description or in the sections specifically checked for these terms.
Yes
The device is intended for medical purposes such as muscle relaxation, increasing blood circulation, and muscle re-education, which classifies it as a therapeutic device.
No
The "Intended Use / Indications for Use" section lists therapeutic applications such as muscle relaxation, increasing blood circulation, and muscle re-education, but does not mention any diagnostic purposes like identifying or characterizing a disease or condition.
No
The device description explicitly states "CS3102 High Voltage Galvanic Stimulator," which is a hardware device used for electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (muscle spasm relaxation, increasing blood circulation, range of motion, preventing atrophy, muscle re-education) are all related to physical therapy and rehabilitation, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: A "High Voltage Galvanic Stimulator" is a device that delivers electrical impulses to the body for therapeutic purposes. This is consistent with physical therapy devices, not IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic device, specifically an electrical stimulator used in physical medicine and rehabilitation.
N/A
Intended Use / Indications for Use
- Relaxation of muscle spasm .
- Increasing local blood circulation .
- Maintaining or increasing range of motion •
- Preventing or retarding disuse atrophy .
- Muscle re-education .
- Intusion is outcales. .
Product codes
IPF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Federal law restricts this device to salc by or on the order of a practitioner so licensed by the law of the state in which he/she practices to use or order the use of the device.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing, representing health and human services.
JUN - 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Control Solutions, Inc. C/o Jeremi Peck Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062
Re: K041146
K041140
Trade/Device Name: CS3102 High Voltage Galvanic Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 27, 2004 Received: May 28, 2004
Dear Mr. Peck:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bottom 3 rQtry pressed is substantially equivalent (for the indications felerenced above and nave actering gally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manage of the Medical Device American so to commerce provided in accordance with the provisions of the Federal Food, Drug, devices may been rechasined in assess asproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, market are act include requirements for annual registration, listing of general controls provisions of uactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), in If your device is classified (soc above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of this be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous ocements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I D7 is issuation of a subside complies with other requirements of the Act that IDA has made a dotermination administered by other Federal agencies. You must of ally if ederal statutes and regarations and limited to: registration and listing (21 comply with an the rece stequirements, on ; good manufacturing practice requirements as set CFK Part 807), raoching (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Jeremi Peck
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA miding of basification of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your don'ter at (301) 594-4659. Also, please note the regulation entitled, Colliact the Oriec of Complance at (21CFR Part 807.97). You may obtain Misbraining by reference to premainterial international on the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L Mark N Milkers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number:
CS3102 High Voltage Galvanic Stimulator Device Name:
Indications For Use:
- Relaxation of muscle spasm .
- Increasing local blood circulation .
- Maintaining or increasing range of motion •
- Preventing or retarding disuse atrophy .
- Muscle re-education .
- Intusion is outcales. .
Federal law restricts this device to salc by or on the order of a practitioner so licensed by the law of the state in which he/she practices to use or order the use of the device.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II: NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices |
| 510(k) Number | K041146 |
|---|---|
| --------------- | --------- |
| Prescription Use ☑ | OR | Over-The-Counter Use ☐ |
|---|---|---|
| ---------------------------------------------------------- | ---- | -------------------------------------------------------------- |
(Per 21 CFR 801.109)